GUEST COLUMNISTS

  • Hybrid Decentralized Trials: Using Technology To Create More Patient-Centric Studies
    Hybrid Decentralized Trials: Using Technology To Create More Patient-Centric Studies

    While it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.

  • Will Authorized Biologics Disrupt The Market For Biosimilars?
    Will Authorized Biologics Disrupt The Market For Biosimilars?

    Many of the doomsday scenario predictions for biosimilar competition if authorized biologics were to enter the space prematurely assume mainstream development and adoption of authorized biologics by innovator companies in the current market and do not take into consideration the outcomes seen over the past 18 years with authorized small molecule generics.

  • Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project
    Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project

    Faced with competing priorities, teams often rush to turn their plans into projects while missing the important steps in between. Resource planning is chief among these oversights. 

  • Achieving Integrated Quality Through A Continued Process Verification Program
    Achieving Integrated Quality Through A Continued Process Verification Program

    Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement. 

  • CDMO Selection: How To Kick Off A Game-Winning Project
    CDMO Selection: How To Kick Off A Game-Winning Project

    This article explores the execution phase of outsourcing with a focus on the context and planning of the kickoff meeting. At this meeting, the handoff from the existing procurement team to the operations team will require close attention.

  • Driving Innovation: Blockchain Adoption For Clinical Trials Optimization
    Driving Innovation: Blockchain Adoption For Clinical Trials Optimization

    Pharmaceutical companies and research institutions are feeling the pressure to reduce the time, financial, and other resource costs associated with conducting clinical trials. With the influx of emerging applications for technologies such as machine learning, robotics and automation, and blockchain and other distributed ledger technologies (DLTs), many see a new path to more efficient and effective processes that can address the challenges faced today.

  • Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework
    Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework

    The FDA's new pharmaceutical quality assessment system is intended to capture and manage information about inherent risk and control approaches for product design, manufacturing, and facilities, in a structured format with the intent to facilitate a concise and consistent quality assessment, and largely replace freestyle text.

  • The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial
    The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.

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PHARMA OUTSOURCING WHITE PAPERS

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OUTSOURCED PHARMA CONTENT COLLECTIONS

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Starting with the editorial, What If Our Generics Strategy Has Been All Wrong?, Outsourced Pharma Chief Editor Louis Garguilo presents this series exploring the subjects of patents and pricing, innovative drugs versus generics, and our entire healthcare system. Learn more in this free collection of articles.

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OUTSOURCING EVENTS

Pharma Meet 2019 | Italy November 18 - 19, 2019
Metropolitan City of Milan, SC
Preparing eCTD Submissions: A Step-By-Step Guide November 19 - 19, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance November 20 - 20, 2019
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Establishing Appropriate Quality Metrics November 21 - 21, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach December 5 - 5, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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